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Natural Orifice Specimen Extraction Surgery for Colorectal Cancer (NOSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT05740267

Recruitment Status : Not yet recruiting

First Posted : February 23, 2023

Last Update Posted : February 23, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Chang Gung Memorial Hospital

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Not yet recruiting
Estimated Primary Completion Date :	November 30, 2025
Estimated Study Completion Date :	November 30, 2025

Publications:

Chiu HM, Jen GH, Wang YW, Fann JC, Hsu CY, Jeng YC, Yen AM, Chiu SY, Chen SL, Hsu WF, Lee YC, Wu MS, Wu CY, Jou YY, Chen TH. Long-term effectiveness of faecal immunochemical test screening for proximal and distal colorectal cancers. Gut. 2021 Dec;70(12):2321-2329. doi: 10.1136/gutjnl-2020-322545. Epub 2021 Jan 25.

Clinical Outcomes of Surgical Therapy Study Group; Nelson H, Sargent DJ, Wieand HS, Fleshman J, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Ota D. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004 May 13;350(20):2050-9. doi: 10.1056/NEJMoa032651.

Green BL, Marshall HC, Collinson F, Quirke P, Guillou P, Jayne DG, Brown JM. Long-term follow-up of the Medical Research Council CLASICC trial of conventional versus laparoscopically assisted resection in colorectal cancer. Br J Surg. 2013 Jan;100(1):75-82. doi: 10.1002/bjs.8945. Epub 2012 Nov 6.

Colon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. doi: 10.1016/S1470-2045(08)70310-3. Epub 2008 Dec 13.

Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.

Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

Scott MJ, Baldini G, Fearon KC, Feldheiser A, Feldman LS, Gan TJ, Ljungqvist O, Lobo DN, Rockall TA, Schricker T, Carli F. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 1: pathophysiological considerations. Acta Anaesthesiol Scand. 2015 Nov;59(10):1212-31. doi: 10.1111/aas.12601. Epub 2015 Sep 8.

Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.

Saad S, Hosogi H. Natural orifice specimen extraction for avoiding laparotomy in laparoscopic left colon resections: a new approach using the McCartney tube and the tilt top anvil technique. J Laparoendosc Adv Surg Tech A. 2010 Oct;20(8):689-92. doi: 10.1089/lap.2010.0303.

Wolthuis AM, de Buck van Overstraeten A, Fieuws S, Boon K, D'Hoore A. Standardized laparoscopic NOSE-colectomy is feasible with low morbidity. Surg Endosc. 2015 May;29(5):1167-73. doi: 10.1007/s00464-014-3784-3. Epub 2014 Aug 23. Erratum In: Surg Endosc. 2015 May;29(5):1174.

Park JS, Choi GS, Kim HJ, Park SY, Jun SH. Natural orifice specimen extraction versus conventional laparoscopically assisted right hemicolectomy. Br J Surg. 2011 May;98(5):710-5. doi: 10.1002/bjs.7419. Epub 2011 Feb 8.

Wolthuis AM, Fieuws S, Van Den Bosch A, de Buck van Overstraeten A, D'Hoore A. Randomized clinical trial of laparoscopic colectomy with or without natural-orifice specimen extraction. Br J Surg. 2015 May;102(6):630-7. doi: 10.1002/bjs.9757. Epub 2015 Mar 12.

Senft JD, Droscher T, Gath P, Muller PC, Billeter A, Muller-Stich BP, Linke GR. Inflammatory response and peritoneal contamination after transrectal natural orifice specimen extraction (NOSE) versus mini-laparotomy: a porcine in vivo study. Surg Endosc. 2018 Mar;32(3):1336-1343. doi: 10.1007/s00464-017-5811-7. Epub 2017 Aug 25.

Franklin ME Jr, Liang S, Russek K. Natural orifice specimen extraction in laparoscopic colorectal surgery: transanal and transvaginal approaches. Tech Coloproctol. 2013 Feb;17 Suppl 1:S63-7. doi: 10.1007/s10151-012-0938-y. Epub 2012 Dec 19.

Cheng CC, Hsu YR, Chern YJ, Tsai WS, Hung HY, Liao CK, Chiang JM, Hsieh PS, You JF. Minimally invasive right colectomy with transrectal natural orifice extraction: could this be the next step forward? Tech Coloproctol. 2020 Nov;24(11):1197-1205. doi: 10.1007/s10151-020-02282-x. Epub 2020 Jul 6.

Jong BK, Cheng CC, Hsu YJ, Chern YJ, Tsai WS, Hung HY, Liao CK, Yeh CY, Hsieh PS, You JF. Transrectal natural orifice specimen extraction in left hemicolectomy for tumours around the splenic flexure: Old wine in new bottles. Colorectal Dis. 2022 Jan;24(1):128-132. doi: 10.1111/codi.15930. Epub 2021 Oct 10.

Zhou ZQ, Wang K, Du T, Gao W, Zhu Z, Jiang Q, Ji F, Fu CG. Transrectal Natural Orifice Specimen Extraction (NOSE) With Oncological Safety: A Prospective and Randomized Trial. J Surg Res. 2020 Oct;254:16-22. doi: 10.1016/j.jss.2020.03.064. Epub 2020 May 8.

Muller PC, Dube A, Steinemann DC, Senft JD, Gehrig T, Benner L, Nickel F, Muller-Stich BP, Linke GR. Contamination After Disinfectant Rectal Washout in Left Colectomy as a Model for Transrectal NOTES: A Randomized Controlled Trial. J Surg Res. 2018 Dec;232:635-642. doi: 10.1016/j.jss.2018.07.066. Epub 2018 Aug 16.

Homma Y, Hamano T, Akazawa Y, Otsuki Y, Shimizu S, Kobayashi H, Kameoka S, Kobayashi Y. Positive peritoneal washing cytology is a potential risk factor for the recurrence of curatively resected colorectal cancer. Surg Today. 2014 Jun;44(6):1084-9. doi: 10.1007/s00595-013-0689-z. Epub 2013 Aug 14.

Salamanca IMG, Jaime MTE, Penco JMM, Martinez JS. Role of Peritoneal Cytology in Patients with Early Stage Colorectal Cancer. Pathol Oncol Res. 2020 Apr;26(2):1325-1329. doi: 10.1007/s12253-019-00706-0. Epub 2019 Aug 10.

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.